A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. The researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Bismuth; Esomeprazole; Furazolidone; Pectin; Rabeprazole; Tetracycline

Criteria

Inclusion Criteria:

• Patients aged 18-70 with persistent H. pylori infection.

• Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

• Patients unable or unwilling to receive gastroscopy.

• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.

• Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.

• History of allergy to any of the drugs used in the study.

• Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.

• Currently pregnant or lactating.

• Severe neurologic or psychiatric disorders.

• Alcohol abuse or drug addiction.

• Patients with compliance lower than 90% in any previous treatment are not included.

• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.